Other than studies coming from a few pioneering academic
medical centers with home grown EMR’s, convincing evidence for a beneficial
effect of EMR’s on patient safety has been scant. But a new study using data
from the Pennsylvania Patient Safety Authority (PPSA) and the HIMSS Analytics
database demonstrates a substantial decrease in patient safety events at hospitals
with advanced EMR’s (Hydari 2014).
Advanced EMR’s were those in which CPOE and physician documentation had been
implemented (as opposed to basic EMR’s which have a clinical data repository
and clinical decision support). The researchers found that advanced EMRs led to
a 27 percent decline in patient safety events overall, driven by a 30 percent
decline in events due to medication errors and 25 percent decline in events due
to complications of tests, treatments and procedures. The results remained
robust after adjustment for multiple factors such as hospital case mix, patient
demographics, teaching status, hospital size, etc.
A strength of the study is that all Pennsylvania hospitals
report patient safety events to the PPSA database. On the other hand, data in
the HIMSS database is self-reported by hospitals and may not be completely
accurate. You’ll also need an advanced degree in biostatistics to understand
all the nuances of their “robustness” checks!
But the data are very encouraging and seem to confirm our
longstanding faith that EMR’s would eventually deliver, at least on the patient
safety side of the equation (the fiscal side may be a different story).
When used well, the data from electronic medical records can
be extremely helpful for quality and patient safety. Alerts and reminders
generated on algorithms using clinical and laboratory elements in the EMR need
to be validated, evidence-based, have good sensitivity and specificity, and be
actionable or provide alternative options, and be delivered to the person most
likely to perform the appropriate intervention (the latter not always being the
physician).
In our November 11, 2014 Patient Safety Tip of the Week “Early
Detection of Clinical Deterioration” we noted how use of data from
electronic sources can was able to detect clinical deterioration early and
reduce mortality rates. Another new study demonstrated that an early warning
and response system for sepsis resulted in a significant increase in early
sepsis care, ICU transfer, and sepsis documentation (Umscheid
2014). There was also a trend toward decreased sepsis mortality and
increased discharge to home that did not reach statistical significance. The
system was based on laboratory values and vital signs from the electronic
health record monitored in real time. If a patient had ≥4 predefined
abnormalities at any single time, the provider, nurse, and rapid response
coordinator were notified and performed an immediate bedside patient
evaluation. And we’ve done several columns on use of decision support tools to
avoid Torsade de Pointes (see our June 10, 2014 Patient Safety Tip of the Week
“Another
Clinical Decision Support Tool to Avoid Torsade de Pointes”.
But not everyone is using EMR’s to their fullest extent and
there continue to be unexpected consequences of EMR’s.
In fact, ECRI Institute has recently released its annual
report on the Top 10 Health Technology Hazards and “Data Integrity: Incorrect
or Missing Data in EHRs and Other Health IT Systems” is #2 on the list for
2015. Among the examples the report identifies in this category are:
Way back when we first began participating in EMR
implementations we recognized the risks of entering information or orders into
the wrong patient’s record (see our May 20, 2008 “CPOE
Unintended Consequences – Are Wrong Patient Errors More Common?”).
We continue to see systems in which a physician can have more than one
patient’s medical record online simultaneously (for example, one might have one
patient’s imaging report showing in a radiology PACS system and another
patient’s record showing on a CPOE screen). It’s easy to see how such “wrong
patient” errors can occur in those circumstances. In fact, this problem is so
prevalent that AHRQ has just awarded a substantial grant to study the problem (Montefiore
News Release 2014).
Even well-intentioned EMR-related projects may result in
unintended consequences. A recent case report showed how trying to fit a
standardized order set into an inflexible EMR resulted in serious consequences
to patients (Manley 2014).
Recognizing that continuous bladder irrigation (sometimes used for patients
with gross hematuria and a few other conditions) was being managed more and
more by staff not very familiar with its use, standardized order sets were
developed. Such irrigation is typically done via low gravity so that pressure
inside the bladder does not rise to dangerous levels. Because the EMR would not
accept infusions without specifying rates, those developing the order set felt
the orders would be similar to IV orders and require rates in the order. Staff
began bladder infusions using infusion pumps, resulting in bladder rupture in
at least one patient. The report goes on to describe how a multidisciplinary
team analyzed cases and worked collaboratively to develop a good standardized
order set.
And, of course, we continue to see that many EMR’s have
notes of various providers in silos such that they are seldom read by others
(see our October 2014 What’s New in the Patient Safety World column “Ebola
Exposes Fundamental Flaw”).
These are but a few examples of the downside of the EMR.
Below are listed some of our prior columns on the unintended consequences of
EMR’s. But the recent study using the PPSA database (Hydari 2014)
is encouraging and suggests that we are finally turning the corner on
fulfilling the promise of EMR’s to improve patient safety.
See some of our other
Patient Safety Tip of the Week columns dealing with unintended consequences of
technology and other healthcare IT issues:
References:
Hydari MZ, Telang
R, Marella WM. Saving Patient Ryan - Can Advanced
Electronic Medical Records Make Patient Care Safer? (September 30, 2014).
Available at SSRN:
http://papers.ssrn.com/sol3/papers.cfm?abstract_id=2503702
Umscheid CA, Betesh
J, VanZandbergen C, et al. Development,
implementation, and impact of an automated early warning and response system
for sepsis. J Hosp Med 2014; Article first published
online: 26 SEP 2014
http://onlinelibrary.wiley.com/doi/10.1002/jhm.2259/abstract
ECRI Institute. ECRI Institute 2015 Top 10 Health Technology
Hazards. A Report from Health Devices. November 2014
Montefiore News Release. AHRQ Grant Awarded to Study the
Impact of Health IT on Patient Safety at Montefiore and Einstein and Brigham
and Women’s Hospital. September 24, 2014
http://www.montefiore.org/body.cfm?id=1738&action=detail&ref=1185
Manley BJ, Gericke RK, Brockman
JA, et al. The pitfalls of electronic health orders: development of an enhanced
institutional protocol after a preventable patient death. Patient Safety in Surgery 2014, 8: 39
http://www.pssjournal.com/content/8/1/39
Print “January
2015 Beneficial Effect of EMR on Patient Safety”
In the late 1980’s
New York State adopted recommendations of the Bell Commission to limit the
number of hours housestaff could work in a week.
Subsequently other states and the ACGME have adopted significant restrictions
in housestaff hours. The ACGME 80-hour work week
restriction was implemented in 2003 and the ACGME in 2011 mandated 16-hour duty
maximums for PGY-1 residents.
These
recommendations have been based on the well-known impact of fatigue on
healthcare workers (see list of our prior columns below). But we suspected even
back in the 1980’s that benefits from reduced housestaff
fatigue might well be offset by detrimental effects of increased cross-coverage
and an increased number of handoffs that would occur after the change in housestaff hours. Significantly, most of the restrictions
on housestaff work hours were implemented without any
formal or systematic measurement of its impact on patient outcomes or for
recognition of unintended consequences.
The subsequent
evidence of the impact of restricted housestaff hours
on patient outcomes and patient safety has been mixed and contradictory (see
list of our prior columns below). And any study looking at the impact of
restricted work hours needs to look at patient outcomes, adverse events, housestaff wellness and well-being, and how well we educate
and prepare our residents for their future practice in healthcare.
Add to those prior
studies several new studies. Two such studies recently appeared in JAMA. In the
first (Patel 2014)
the authors found no significant
differences among Medicare beneficiaries in the change in 30-day mortality
rates or 30-day all-cause readmission rates for those hospitalized in more
intensive relative to less intensive teaching hospitals in the year after
implementation of the 2011 ACGME duty hour reforms compared with those
hospitalized in the 2 years before implementation.
The second study (Rajaram 2014)
found that implementation of the 2011
ACGME duty hour reform was not associated with a change in general surgery
patient outcomes or differences in resident examination performance.
In addition, another
systematic review (Harris 2014)
found some support for improved resident quality of life and improved resident
sleep and less fatigue but a perceived negative impact on surgical operative
and technical skill and conflicting evidence on the topics of resident
education, patient outcomes, and variable attitudes toward the work-hour
changes. The authors again noted there is a paucity of high-level or clear
evidence evaluating the effect of the changes to resident work hours.
Virtually all the
studies to date have been observational studies, usually with a before-after
format. Most of us have doubted that a true randomized controlled trial could
ever be done regarding the impact of workhour
restrictions. But, in fact, two such trials are planned, with support from the
ACGME. The FIRST Trial
will be a prospective trial to examine how increasing flexibility of surgical
resident duty hour requirements affects patient care, surgical outcomes, and
resident perceptions. Hospitals will be randomized to either an intervention
group with flexibility of duty hour restrictions (elimination of many duty hour
requirements) or a control group with continued adherence to current
requirements. Those hospitals randomized to the intervention arm will be granted
a waiver from current duty hour requirements by the ACGME.
The iCOMPARE trial is a one-year cluster randomized trial
that will assign participating ACGME-accredited Internal Medicine training
programs to one of two duty-hour regimens:
Outcomes include
measures of patient safety and trainee education. The ACGME will provide duty
hour waivers to all participating programs from July 2015 through at least June
2019 (or until action is taken on duty hour policy).
Let’s hope these two
trials can help answer some of the questions outstanding regarding multiple
aspects of the impact of resident work hour restrictions.
Some of our other columns on housestaff
workhour restrictions:
December 2008 “IOM
Report on Resident Work Hours”
February 26, 2008 “Nightmares:
The Hospital at Night”
January 2010 “Joint
Commission Sentinel Event Alert: Healthcare Worker Fatigue and Patient Safety
January 2011 “No
Improvement in Patient Safety: Why Not?”
November 2011 “Restricted
Housestaff Work Hours and Patient Handoffs”
January 3, 2012 “Unintended
Consequences of Restricted Housestaff Hours”
June 2012 “Surgeon
Fatigue”
November 2012 “The
Mid-Day Nap”
December 10, 2013 “Better
Handoffs, Better Results”
April 22, 2014 “Impact
of Resident Workhour Restrictions”
Some of our other columns on the role of fatigue in
Patient Safety:
November 9, 2010 “12-Hour
Nursing Shifts and Patient Safety”
April 26, 2011 “Sleeping
Air Traffic Controllers: What About Healthcare?”
February 2011 “Update
on 12-hour Nursing Shifts”
September 2011 “Shiftwork
and Patient Safety
November 2011 “Restricted
Housestaff Work Hours and Patient Handoffs”
January 2010 “Joint
Commission Sentinel Event Alert: Healthcare Worker Fatigue and Patient Safety
January 3, 2012 “Unintended
Consequences of Restricted Housestaff Hours”
June 2012 “June
2012 Surgeon Fatigue”
November 2012 “The
Mid-Day Nap”
November 13, 2012 “The
12-Hour Nursing Shift: More Downsides”
July 29, 2014 “The
12-Hour Nursing Shift: Debate Continues”
October 2014 “Another
Rap on the 12-Hour Nursing Shift”
December 2, 2014 “ANA
Position Statement on Nurse Fatigue”
References:
Patel MS, Volpp KG, Small DS, et
al. Association of the 2011 ACGME Resident Duty Hour Reforms With
Mortality and Readmissions Among Hospitalized Medicare Patients. JAMA 2014;
312(22): 2364-2373
http://jama.jamanetwork.com/article.aspx?articleid=2020371
Rajaram R, Chung JW, Jones AT, et
al. Association of the 2011 ACGME Resident Duty Hour Reform With General
Surgery Patient Outcomes and With Resident Examination Performance. JAMA 2014;
312(22): 2374-2384
http://jama.jamanetwork.com/article.aspx?articleid=2020372
Harris JD, Staheli G, LeClere L, et al. What Effects Have Resident Work-hour
Changes Had on Education, Quality of Life, and Safety? A Systematic Review. Clinical
Orthopaedics and Related Research 2014; October 2014 Published online: 01 Oct 2014
http://link.springer.com/article/10.1007%2Fs11999-014-3968-0
The FIRST Trial. Flexibility In duty hour Requirements for
Surgical Trainees Trial.
http://www.thefirsttrial.org/Overview/Overview
iCOMPARE
Trial (Comparative Effectiveness of Models
Optimizing Patient Safety and Resident Education)
http://www.jhcct.org/icompare/default.asp
Print “January
2015 More Data on Effect of Resident Workhour
Restrictions”
Surgery done on an
emergency basis and surgery done “after-hours” is associated with more
complications, more morbidity, and often more mortality (see our What’s New in
the Patient Safety World columns for September 2009 “After-Hours
Surgery – Is There a Downside?”, October
2014 “What
Time of Day Do You Want Your Surgery?”, and December 2014 “Another
Procedure to Avoid Late in the Day or on Weekends”).
One consideration
we’ve not discussed much is cost. Cases done after hours have variable
costs higher than those done during normal hours (overtime, etc.) and the
resultant increase in complications and morbidity have additional incremental
costs as well. Since most cases are reimbursed with DRG or similar methodology
hospitals seldom recoup the full incremental costs of doing such cases after
hours.
Now a new study has assessed the financial impact of
emergency vs. elective surgery (Haider
2014). Using Nationwide
Inpatient Sample (NIS) data the authors investigated costs and mortality for
three procedures: abdominal aortic aneurysm repair, coronary artery bypass
graft, or colon resection for neoplasm. The adjusted mean cost differences for
emergent versus elective care ranged from $5309.78 to $8741.22 for the three
procedures. The authors estimate that if 10% of the weighted estimates of
emergency procedures had been performed electively, the cost benefit would have
been nearly $1 billion. Elective surgery patients had significantly lower
adjusted odds of mortality for all procedures.
Of course, there are big differences between the types of
cases described by Haider et al. and those we have
previously described. Most of the ones we’ve discussed are not likely true
emergencies (even though they are often categorized as such). Those described
by Haider et al. probably were truly emergent (eg. rupture of an AAA, bowel obstruction from a colon
cancer, etc.). Moreover, the three conditions chosen for analysis by Haider et al. are ones where access to primary care and
screening may have led to earlier detection and interventions that need not be
done on an emergent basis. The message in the Haider
study, therefore, is important for health plans and accountable care
organizations as well as hospitals.
Nevertheless, you get the picture: surgeries that can be
done on an elective rather than emergency basis are less costly – from both a
human and financial perspective. We again urge all hospitals to take a look at
surgeries and procedures done “after hours” and determine how often such cases
are truly “emergent”. When you identify those that were not truly “emergent”
you need to do root cause analyses and identify what factors contributed to the
decision to intervene after hours and which could be potentially modifiable by
system changes.
Why should “after
hours” surgery be more prone to adverse outcomes than regularly scheduled
elective surgery? There are many reasons aside from the fact that patients
needing emergency and after hours surgery are generally sicker. You are
operating with a team that is likely different from your daytime team. All
members of that team (physicians, nurses, anesthesiologists, techs, etc.) may
not have the same level of expertise as your regular daytime team and the team
dynamics between members is likely to be different. The post-surgery recovery
unit is likely to be staffed much differently after-hours as well. The staff
may be more likely to be unfamiliar with things like location of equipment. And
some of the other hospital support services (eg.
radiology, laboratory) may have lesser staffing after-hours. Just as
importantly, many or all of the “on-call” staff that make up the after-hours
surgical team have likely worked a full daytime shift that day so fatigue
enters as a potential contributory factor. And there are always time pressures
after hours as well. In addition, one of the most compelling reasons surgery is
done at night rather than deferred to the next morning is the schedule of the
surgeon or other physician for that next morning (either in surgery or the cath lab or his/her office). Because the surgeon does not
want to disrupt that next day schedule, he/she often prefers to go ahead with
the current case at night. Similarly, many hospitals run very tight OR
schedules and adding a case from the previous night can disrupt the schedule of
many other cases.
We highly
recommend hospitals take a hard look at surgical cases done “after hours”. In
particular, you need to determine which cases truly needed to be done after
hours and, perhaps more importantly, which ones could have and should have been
done during “regular hours”. If the latter are significant, you need to
consider system changes such as reserving some “regular hours” for such cases to
be done the following morning. You may have to alter the scheduling of cases
for individual surgeons as well. For example, perhaps the surgeon on-call
tonight should not have elective cases scheduled tomorrow morning. That way, if
a case comes in tonight that should be done tomorrow morning you will have both
a “free” OR room and a “free” surgeon. And you would need to develop a list of
criteria to help you triage cases into “regular” or “after-hours” time slots.
References:
Haider AH, Obirieze
A, Velopulos CG, et al. Incremental Cost of Emergency
Versus Elective Surgery. Annals of Surgery 2014;
published online ahead of print December 17, 2014
Print “January
2015 Emergency Surgery Also Very Costly”
Each year ECRI Institute puts out its list of the top 10
health technology hazards. The ECRI
Institute Top 10 Health Technology Hazards for 2015 list is now out:
As usual, ECRI Institute provides excellent recommendations
at preventing or mitigating the impact of incidents related to each of these
hazards.
Issues related to alarm management and information
technology dominate the list. Leading the list again is alarm hazards and this
should be no surprise. But alarm issues leading to ventilator disconnections
got its own place on this year’s list. Robotic surgery and inadequate
reprocessing of endoscopes and instruments are holdovers from last year. Issues
related to patient-handling devices (lifts, transfer devices, etc.) may not
sound particularly hi-tech but staff need education on the use and maintenance
of all such devices. Similarly, the focus on IV’s this year is not so much on
the hi-tech infusion devices but rather on making sense out of the tangle of IV
lines linked to our sickest patients. Also new to this year’s list is hazards
related to recall and safety alerts. We’re pleased to see that make the list.
Our February 26, 2013 Patient Safety Tip of the Week “Insulin
Pen Re-Use Incidents: How Do You Monitor Alerts?” highlighted the problem
of hospitals having inadequate systems to deal with such alerts or recalls.
We won’t steal ECRI’s thunder. Read the report yourself. The
full report can be downloaded
free at the ECRI Institute website. This is a very informative and useful
document that you should make full use of.
References:
ECRI Institute. ECRI Institute Announces Top 10 Health
Technology Hazards for 2015. Press Release November 25, 2014
report download site:
https://www.ecri.org/Pages/2015-Hazards.aspx
Print “January
2015 ECRI Institute’s Top 10 Technology Hazards for 2015”
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2015 What's New in the Patient Safety World (full
column)”
Print “January
2015 Beneficial Effect of EMR on Patient Safety”
Print “January
2015 More Data on Effect of Resident Workhour
Restrictions”
Print “January
2015 Emergency Surgery Also Very Costly”
Print “January
2015 ECRI Institute’s Top 10 Technology Hazards for 2015”
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